Tofacitinib Citrate residual solvent GC detection method

A technology of tofacitinib and its detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as the inability to determine the specific content and the determination of solvent residues, and achieve the effects of high accuracy, simple detection method, and high sensitivity
CN110286160AInactive Publication Date: 2019-09-27NANJING GRITPHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
NANJING GRITPHARMA CO LTD
Publication Date
2019-09-27
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention relates to the technical field of drug analysis, in particular to a gas-liquid chromatography detection method of a tofacitinib citrate residual solvent. The method comprises the following steps of: configuring an analysis solution; setting chromatographic conditions; and performing determination on a machine. The method can effectively determine the content of the tofacitinib citrate residual solvent, thereby ensuring the controllable quality of the product.
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Description

technical field

[0001] The invention relates to the technical field of drug analysis, in particular to a gas-liquid chromatography detection method for tofacitinib citrate residual solvents. Background technique

[0002] The so-called "residual solvent" in drug analysis refers to the organic solvent used in the production process of raw materials or excipients, as well as in the preparation of preparations, but not completely removed in the process. The selection of a suitable solvent in the synthesis of raw materials is an essential key factor in the synthesis process, which can improve the yield and determine the properties of the drug, such as crystal form, purity, dissolution rate, etc. Residual solvents are an important class of impurities in drugs. They are toxic or carcinogenic. When the level is higher than the safe value, they will cause harm to the human body or the environment. Therefore, the detection of residual solvents in drugs is an important part of drug qua...

Claims

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